Recall Z-0945-2023 ยท LRS I.V. Start Kit
Stradis Healthcare
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
| Date | Jan 11, 2023 (initiated Dec 15, 2022) |
| Status | Open, Classified |
| Reason | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
| Root cause | Process control |
| Action | Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form. |
| Quantity | 1,175 units |
| Distribution | US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.